Plaintiff
initially filed this lawsuit against defendant Teva
Pharmaceuticals USA, Inc., d/b/a Gate Pharmaceuticals in
circuit court in Cape Girardeau County, Missouri. Defendant
removed the matter to this Court pursuant to this Court's
diversity jurisdiction, 28 U.S.C. § 1332(a)(1). The
lawsuit alleges that defendant Teva developed, manufactured,
and marketed the prescription weight-loss drug Phentermine in
its generic form and the brand name drug Adipex P. Plaintiff
claims that defendant Teva failed to warn that Phentermine
and Adipex P cause blood clots and that she was injured when
she took these products. She claimed Teva was liable for
Failure to Warn and Design Defect (Count I) and in Strict
Liability (Count II). After removal to this Court, plaintiff
amended her complaint to add defendants the United States
Food and Drug Administration (“FDA”),
Commissioner of Food and Drugs Robert Califf in his official
capacity, and Secretary of Health and Human Services Sylvia
Matthews Burwell in her official capacity (the “federal
defendants”). Plaintiff added Count III against the
federal defendants for a declaratory judgment that FDA
policies and procedures that prevent generic drug
manufacturers from warning consumers about the risks of their
products are arbitrary, capricious, unreasonable, and void as
against public policy.

Defendant
Teva moved to dismiss plaintiff's complaint. The Court
granted that motion because the Supreme Court of the United
States has held that the makers of generic drugs may not be
sued under state law for failing to warn customers about the
risks associated with their products. PLIVA, Inc. v.
Mensing, 564 U.S. 604, 618 (2011); see #15 at
¶¶ 32, 36. Counts I and II were dismissed on
November 28, 2016.

The
federal defendants have now moved to dismiss Count III. The
matter has been fully briefed and is now ready for
disposition.

I.
Legal Standard

The
purpose of a Rule 12(b)(6) motion to dismiss for failure to
state a claim is to test the legal sufficiency of a complaint
so as to eliminate those actions “which are fatally
flawed in their legal premises and deigned to fail, thereby
sparing litigants the burden of unnecessary pretrial and
trial activity.” Young v. City of St. Charles,
244 F.3d 623, 627 (8th Cir. 2001) (citing Neitzke v.
Williams, 490 U.S. 319, 326-27 (1989)). “To
survive a motion to dismiss, a claim must be facially
plausible, meaning that the ‘factual content. . .
allows the court to draw the reasonable inference that the
defendant is liable for the misconduct alleged.'”
Cole v. Homier Dist. Co., Inc., 599 F.3d 856, 861
(8th Cir. 2010) (quoting Ashcroft v. Iqbal, 556 U.S.
662, 678 (2009)).

II.
Discussion

The
Supreme Court held in Mensing that because generic
drug manufacturers are required by federal law to use the
same warning label as its name-brand counterpart, federal law
preempted state laws that might otherwise require the
manufacturer to label its drug to warn of product dangers.
564 U.S. at 618. Plaintiff claims the “policies and
procedures the FDA employs that prevent generic drug
manufacturers from warning consumers/patients about the risks
of their products are arbitrary, capricious, unreasonable and
void as against public policy.” (#15 at ¶ 35.)
Plaintiff states that the Supreme Court relied on those
“void policies and procedures” when it made its
ruling in Mensing.

Plaintiff
thus asks the Court to declare that the “policies and
procedures the FDA employs that prevent generic drug
manufacturers from warning consumers/patients about the risks
of their products are arbitrary, capricious, unreasonable and
void as against public policy” and to allow plaintiff
to proceed with prosecution of her claims against Teva.

The
federal defendants make several arguments in favor of
dismissing plaintiff's claims against them.

Defendant's
arguments for dismissal for failure to state a claim under
Federal Rule of Civil Procedure 12(b)(6) include that she
failed to exhaust administrative remedies, that she failed to
challenge a specific policy or procedure, and that she failed
to identify an applicable waiver of sovereign immunity.

Exhaustion
of administrative remedies is generally required before
proceeding to federal court to see review of the actions or
policies of a federal administrative agency. Darr v.
Carter, 640 F.2d 163, 165 (8th Cir. 1981). The
Administrative Procedure Act (“APA”) authorizes
judicial review only with respect to “final agency
action, ” 5 U.S.C. § 704, and an agency action is
final for purposes of the APA only after a plaintiff
“has exhausted all administrative remedies expressly
prescribed by statute or agency rule.” Darby v.
Cisneros, 509 U.S. 137, 146 (1993). The Court notes that
exhaustion requirements are not without exception, and the
“general test” applied by the Court
“permits resort to the courts without exhaustion when a
litigant's need for immediate judicial review outweighs
the efficiency and administrative autonomy that the
exhaustion doctrine is designed to further.”
Darr, 640 F.2d at 165.

Defendants
point out that plaintiff has made no attempt to avail
herself, much less exhaust, the administrative remedy
available to her, which is to file a citizen petition with
the FDA pursuant to 21 C.F.R. §§ 10.25 and 10.30.
FDA regulations require that “before any legal action
is filed in a court, ” a party must first use the
citizen petition process to “request that the
Commissioner take or refrain from taking any form of
administrative action.” 21 C.F.R. § 10.45(b). That
same regulation requires the Commissioner to request
dismissal of the court action “for an initial
administrative determination on the grounds of a failure to
exhaust administrative remedies” in the event such an a
court action is filed before a citizen petition. Id.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Defendants
states that plaintiff should have requested the FDA to
consider the issues in this matter and apply the agency&#39;s
interpretation of the labeling regulations to these facts,
including (1) whether Teva could have unilaterally changed
the phentermine and Adipex-P labeling through a
changes-being-effected or &ldquo;CBE&rdquo; submission, and
(2) whether a labeling regime other than the one at issue in
Mensing might apply to Adipex-P and the generic
phentermine at issue here.[1] Any interested person ---
e.g., Teva --- could thereafter submit comments and
present alternative views. ...

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